National hip implant trial begins
in Dallas
Byron Harris, 1:51 p.m. CDT September 4, 2014
Plaintiffs claim the DePuy Pinnacle hip was not properly tested before being
marketed to orthopedic surgeons
DALLAS — A national court case involving thousands of hip
implant patients suing a subsidiary of Johnson &
Johnson is now underway in Dallas.
The focus is the DePuy Pinnacle
hip, which the company quit selling in August 2013.
The pool of plaintiffs is so large that a handful of
so-called "bellwether" plaintiffs have been selected from more than 6,000 people who have
filed suit. This smaller pool of cases will be argued before juries, and
the verdicts will be used to determine settlements against Johnson &
Johnson.
Opening arguments in Kathleen Herlihy-Paoli vs. DePuy began Wednesday
before U.S. District Judge Ed Kinkeade in downtown Dallas.
Paoli, of Missoula, Montana, got a DePuy Pinnacle implant
in 2009. She has now had a
combined total of five implants on both her hips, and was hurt by
metal-on-metal wear in the DePuy devices that were placed in her body.
Metal-on-metal wear
of chrome and cobalt components can create adverse health
effects in some patients.
Paoli's attorney, Mark Lanier of Houston, argued that
DePuy did not properly test the Pinnacle device before releasing it to the
market. Under an FDA
provision called 510K, medical devices that substantially resemble other
devices already on the market can be released with less stringent
testing than original designs.
Lanier told the jury that DePuy ignored failures of the Pinnacle device, and
made hundreds of millions of dollars in profits while marketing the
device to orthopedic surgeons.
DePuy's attorney, Richard Sarver of New Orleans, said
Paoli's problems were caused by improper implantation of the device. He also
contended that DePuy never improperly paid physicians to use its devices, and
that the medical community has long known of the risks of metal particles.
Joleen Chambers of the Failed Implant Device Alliance
has been arguing for increased scrutiny of medical devices for years.
"Before these companies get to market their product,
they should have post-market surveillance in place so we can track the devices
in real time, permanently," she told News 8.
Chambers has been a vocal opponent of the FDA's role in
approving hip implants. "It's [the FDA] not working to prove that these
devices are safe before they go to market," she said.
The trial is expected to continue for several weeks.
Last fall, Johnson
& Johnson settled a case for $2.5 billion relating to another DePuy hip
design involving 8,000 patients.
E-mail bharris@wfaa.com
COURTROOM RULES DO NOT ALLOW PATIENT ADVOCATE TO TAKE NOTES ON COMPUTER
FOLLOW THE TRIAL HERE.
COURTROOM RULES DO NOT ALLOW PATIENT ADVOCATE TO TAKE NOTES ON COMPUTER
FOLLOW THE TRIAL HERE.
Director, Federal Affairs, Medical Devices
Johnson & Johnson - Washington, DC, US
Posted September 4, 2014
Job description
Director, Federal Affairs,
Medical Devices-8659140703
Johnson & Johnson is
currently recruiting for a Director, Federal Affairs, Medical Devices. This
position is located in Washington, DC and requires up to 25% travel.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for
over 125 years. We embrace research
and science -- bringing innovative ideas, products and services to advance the
health and well-being of people. Employees of the Johnson & Johnson Family
of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the
world.
With $71.3 billion in 2013 sales, Johnson & Johnson is the world's
most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer,
pharmaceutical, and medical devices and diagnostics markets. The more than 250
Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries
throughout the world.
Thriving on a diverse company
culture, celebrating the uniqueness of our employees and committed to
inclusion. Proud to be an equal opportunity employer.
The Director, Federal Affairs will be responsible to develop, implement
and direct federal lobbying activities in support of the corporation’s medical
device legislative and policy priorities primarily focused on J&J’s Global
Orthopedics business (world’s largest orthopedics company).
A key component of the position
is to represent the corporation both internally and externally on federal
affairs matters relating to the
Centers for Medicare and Medicaid Services, Food and Drug Administration,
congressional relations, Administration outreach, relevant trade associations
and affiliated patient and physician stakeholder organizations. Some of
the official assignments may also require coordination with additional business
partners including the pharmaceutical and consumer operations within the
Enterprise.
The Director, Federal Affairs
will work internally and externally on matters relating to the specific medical
device & diagnostics businesses in collaboration with specific franchises
as well as represent federal affairs on numerous broader-based healthcare issues
and activities. He or she will also work on health care policy and corporate
priority assignments within US Government Affairs as determined by managers,
such as building
relationships with identified stakeholders i.e.: congressional caucuses,
patient, physician and other professional societies and stakeholder
organizations.
This position requires the
incumbent to interact with internal J&J colleagues including US Government
Affairs, International, Health Policy Group, J&J Corporate Communications,
Law, J&J operating company and Corporate personnel and senior management –
specifically J&J’s Global Orthopedics business. External customers including: Members of the US
Congress, Administration, state officials and additional J&J customers.
This position will report to the Senior Director, Federal Affairs, Medical
Devices & Diagnostics.
Qualifications
A minimum of a Bachelor’s Degree is required.
An MBA, Masters, JD and/or equivalent graduate degree is preferred with
concentration in healthcare policy, political science, communications or
business administration preferred. A proven record of success in policy
development and advocacy is required. A minimum of 10 years of experience in
government affairs or public policy is required. A minimum of 5 years of health
policy experience is required. Thorough knowledge of communications, Federal
and/or State government policy and legislative process is required. Candidate
must be a self-starter with exceptional initiative and ability to work
effectively with minimal supervision. Excellent oral and written skills are
required.
BE VITAL in your Career; be seen
for the talent you bring to your work. Explore opportunities within the Johnson
& Johnson Family of Companies.
Primary Location:North America-United States-District of Columbia-Washington
Organization: Johnson & Johnson Services Inc. (6090)
Job Function: Government Affairs
Certain sites within the Johnson
& Johnson Family of Companies participate in E-Verify as appropriate in
accordance with Company guidelines and federal or state law. To learn more
about the government sponsored program and to see a list of the sites that are
currently enrolled, please click here.
Johnson and Johnson Family of
Companies are equal opportunity employers, and all qualified applicants will
receive consideration for employment without regard to race, color, religion,
sex, national origin, protected veteran status, or disability status, or any
other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
About this company
Caring for the world, one person
at a time... inspires and unites the people of Johnson & Johnson. We
embrace research and science - bringing innovative ideas, products and services
to advance the health and well-being of people. Employees of the Johnson &
Johnson Family of Companies work with partners in health care to touch the
lives of over a billion people every day, throughout the world.
Our Family of Companies
comprises:
The world's premier consumer
health company.
The world's largest and most diverse medical devices and diagnostics
company.
The world's third-largest
biologics company.
And the world's sixth-largest
pharmaceuticals company.
We have more than 250 operating
companies in 57 countries employing 120,200 people. Our worldwide headquarters
is in New Brunswick, New Jersey, USA.
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Follow us at @JNJCareers and @JNJuniversity for career tips, J&J news and
inside information on what it is like to work at J&J.
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